Hard Case, Bad Law

The Washington Times (Washington, DC), May 9, 2006 | Go to article overview

Hard Case, Bad Law


Byline: Bruce Fein, SPECIAL TO THE WASHINGTON TIMES

Hard cases make bad law. That adage explains the concoction by a federal appeals court of a constitutional right of terminally ill patients to override the Food and Drug Administration's dubious restrictions on the sale of new drugs in Abigail Alliance for Better Access to Developmental Drugs v. Esenbach (May 2, 2006). As Justice Benjamin Cardozo taught, the Constitution leaves room for large slabs of government folly.

Paternalism is the signature of the FDA. Generally speaking, patients are denied the opportunity to purchase drugs with a full awareness of their risks and benefits unless they have been proven both safe and effective to the FDA. The approval process typically consumes about seven years and hundreds of millions of dollars. The incentive to discover new drugs is dulled, especially for rare diseases with a small customer base. During the seven-year approval process, countless patients are foreclosed from curing or alleviating their afflictions.

The Abigail Alliance litigation emerged from the FDA's three-phased approach to approving new drugs. Phase I tests the drugs on 20 to 80 human subjects to determine "the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness."

Drugs that survive Phase I are viewed by the FDA as safe enough for more ambitious human testing. Phase II entails controlled clinical studies of up to several hundred human subjects "to evaluate the effectiveness of the drug .. and to determine [its] common short-term side effects and risks," Phase III expanded trials involving several thousands of human subjects "gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug."

Only after the completion of Phase III is a drug eligible for FDA approval for commercial marketing, which means a seven-year wait for every new drug.

The Alliance assailed the constitutionality of the FDA's policy barring the sale of post-Phase I investigational new drugs seemed sufficiently safe for additional human testing. The complaint alleged that the effect has been to deny terminally ill patients the choice to use the drugs despite their willingness to assume the risks if their physicians advise them that a treatment may save or prolong their lives and there are no other prospects for escaping imminent death.

The policy argument underlying the constitutional claim seems faultless. The terminally ill are naturally desperate for cures. Their risk-benefit analysis as guided by their physicians is simple and unanswerable. Without the investigative new drug, death awaits. With the drug, life may be saved or prolonged. Rational patients and their families naturally embrace hope over resignation. …

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